BL-M14D1 Plus Atezolizumab for Extensive-Stage Lung Cancer
BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01)
Recruiting
Phase 3Interventional Study
Small Cell Lung Cancer Extensive StageSmall-cell Lung CancerSmall Cell CarcinomaSclcSCLC,Extensive StageLung CancerLung Cancer MetastaticLung Cancer Stage IV
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
550 (estimated)
Sponsor
SystImmune Inc. · Industry
Who this trial is looking for
This trial is looking for adults with extensive-stage small cell lung cancer who have not received treatment before. Participants will receive a combination of two medications, BL-M14D1 and Atezolizumab, to see how well it works compared to standard therapy.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with extensive-stage small cell lung cancer.
I can receive a platinum-based chemotherapy with an anti-PD-L1 inhibitor.
I have at least one measurable tumor.
My performance status is 0 to 1.
I have adequate organ function.
You may not be able to join if
I received platinum or etoposide treatment for limited-stage small cell lung cancer in the last 6 months.
I have received prior topoisomerase inhibitor-based therapy.
I have a history of severe heart disease.
I have active autoimmune or inflammatory diseases.
I have other cancers except for certain skin cancers if treated.
I have had another cancer in the last 3 years.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The objective of the study is to evaluate the efficacy and safety of BL-M14D1 in combination with Atezolizumab compared to Standard-of-Care Therapy in adult participants with previously untreated extensive-stage small cell lung cancer (ES-SCLC).
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Histologically or cytologically confirmed first-line (1L), extensive-stage (ES) small cell lung cancer (SCLC)
* Must be eligible to receive a platinum-based chemotherapy regimen in combination with an anti-PD-L1 inhibitor.
* At least one measurable lesion based on RECIST v1.1 …
Inclusion Criteria:
* Histologically or cytologically confirmed first-line (1L), extensive-stage (ES) small cell lung cancer (SCLC)
* Must be eligible to receive a platinum-based chemotherapy regimen in combination with an anti-PD-L1 inhibitor.
* At least one measurable lesion based on RECIST v1.1 per investigator assessment.
* An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1.
* Adequate organ function
Exclusion Criteria:
* Received any kind of platinum or etoposide treatment for limited stage (LS) SCLC within 6 months prior to enrollment.
* Participants who have received prior topoisomerase inhibitor-based ADC therapy.
* Participants with history of severe heart disease
* Participants with active autoimmune diseases and inflammatory diseases,
* Participants with other prior or concurrent malignancies except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ after adequate resection, or other malignancy treated with curative intent with a disease-free interval of at least 3 years
* Other protocol-defined inclusion/exclusion criteria apply.
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